This course is no longer available. Click here for information about the upcoming course starting in September 2025.
Semmelweis University offers the „Pharmacovigilance in practice – Good Vigilance Practice” accredited course organized by the Department of Pharmacology and Pharmacotherapy.
The course provides a wide picture of EU and Hungarian regulations in relation to drug, medical device, and food supplements safety. The lecturers have different backgrounds ensuring that the participants receive the most up-to-date information (Academia, Hungarian National Institute of Pharmacy and Nutrition (NNGYK), leading regional pharmaceutical companies)
Application form:
Language: English
Location: Online: Zoom
Date: 2024.09.19 – 2024.09.20
Price: 95 000 HUF
For registration please fill out the following online application form, and/or contact us via email: pharma.education@semmelweis.hu
Please, do not hesitate to contact us (pharma.education@semmelweis.hu) in case you need further information or have questions.
Basic data
| Main title | Pharmacovigilance in practice – Good Vigilance Practice |
|---|---|
| Code number | |
| Semester | II. semester 2024 |
| Nature | Optional |
| Condition | Qualified program |
| Organizer | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
| Contact person | Dr. Anikó Görbe, 2104416 |
| Target group | 1. internal medicine | 2. internal medicine angiology | 3. vascular surgery 4. pharmacology | 5. gastroenterology | 6. family medicine 7. neurosurgery | 8. cardiology | 9. hand surgery 10. clinic.lab.exam. (hygiene.) | 11. clinical biochemist | 12. clinical pharmacology 13. clinical oncology | 14. thoracic surgery | 15. molecular biological diagnostician 16. molecular genetic diagnostics | 17. nephrology | 18. neurology 19. neuroradiology | 20. orthopedics | 21. orthopedics and traumatology 22. medical laboratory diagnostics | 23. radiology | 24. rehabilitation medicine 25. rheumatology | 26. surgery | 27. sports medicine 28. heart surgery | 29. traumatology |
| University | Vocational and Continuing Education Center of Semmelweis University |
| Accr.point | 20 |
| Start | 19.09.2024 |
| End | 20.09.2024 |
| Location | Zoom platform |
| Days | 2 |
| Course hours | 16 |
| Exam | yes |
| Price | 95000 HUF |
| Application deadline | 13.09.2024 |
| Website (more information about the course) | https://semmelweis.hu/pharmacology/oktatas/posztgradualis-tanfolyamok/a-farmakovigilancia-gyakorlatban-good-vigilance-practice/ |
| Can participants register on the portal? | Yes |
List of lectures
| Index | Day | Appoint. | Duration (min.) | Title of the presentation | Performer | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
|---|---|---|---|---|---|---|
| 0. | 19.09.2024 Thursday | 08:45 | 15 | Welcoming and introduction Learning outcome | Dr. Mátyás Pétervári | Senior PV Compliance Manager, deputy QPPV; Global Regulatory Science Directorate / Global Patient Safety Department / Global Pharmacovigilance Compliance Unit, Richter Gedeon Plc. |
| 1. | 19.09.2024 Thursday | 09:00 | 60 | GVP Modul I – II Pharmacovigilance systems, Pharmacovigilance system master file Specialized topic: Management of PSMF, and PVAs | Dr. Gábor Erdei | GMP/GDP/GVP Inspector, Hungarian NCA |
| 2. | 19.09.2024 Thursday | 10:00 | 45 | GVP Modul III Inspection | Hatem Adel Ph.D. | |
| 19.09.2024 Thursday | 10:45 | 15 | BREAK | Aurobindo APL Swift Services (Malta) Ltd. | ||
| 3. | 19.09.2024 Thursday | 11:00 | 30 | GVP Modul IV - audits | Barbara Reithauser-Nyíri | Head of Department, Egis Gyógyszergyár Zrt. |
| 4. | 19.09.2024 Thursday | 11:30 | 45 | GVP Modul V - VII - Risk management systems; Periodic safety update report | Dr. Viktória Kis | |
| 19.09.2024 Thursday | 12:15 | 45 | LUNCH BREAK | Case management team leader, Egis Gyógyszergyár Zrt. | ||
| 5. | 19.09.2024 Thursday | 13:00 | 45 | GVP Modul VI – Management of reports of suspected adverse reactions | Dr. Kristóf Kovács | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
| 6. | 19.09.2024 Thursday | 13:45 | 60 | GVP Modul IX – Signal management | Dr. Mátyás Pétervári | |
| 19.09.2024 Thursday | 14:45 | 15 | BREAK | PRAC member, NNGYK | ||
| 7. | 19.09.2024 Thursday | 15:00 | 30 | GVP Modul VIII and X | Dr. Júlia Pallós | PRAC member, NNGYK |
| 8. | 19.09.2024 Thursday | 15:30 | 30 | GVP Modul XV and XVI | Dr. Júlia Pallós | Position/academic degree |
| Index | Day | Appoint. | Duration (min.) | Title of the presentation | Performer | MTA doctor, Semmelweis University (SU) |
| 9. | 20.09.2024 Friday | 08:45 | 45 | Challanges of drug safety considering innovative drug development. | Prof. Dr. Péter Ferdinandy /Dr. Anikó Görbe | university professor/university associate professor |
| 10. | 20.09.2024 Friday | 9:30 | 60 | MDR – Medical device vigilance, introduction | Dr. Ágnes Horváth | CE Certiso Ltd. |
| 20.09.2024 Friday | 10:30 | 15 | BREAK | |||
| 11. | 20.09.2024 Friday | 10:45 | 45 | Future data sources for pharmacovigilance use | Maurizio Sessa | |
| 12. | 20.09.2024 Friday | 11:30 | 45 | Artificial intelligence and drug safety | Jan Petracek | Institute of Pharmacovigilance |
| 20.09.2024 Friday | 12:15 | 45 | LUNCH BREAK | |||
| 13. | 20.09.2024 Friday | 13:00 | 45 | Ecopharmacovigilance | Joan Dsouza | ISOP |
| 14. | 20.09.2024 Friday | 13:45 | 45 | Engagement of HCP for pharmacovigilance | Dr. Máté Ádám Balázs | Semmelweis University |
| 20.09.2024 Friday | 14:30 | 15 | BREAK | |||
| 15. | 20.09.2024 Friday | 14:45 | 45 | Pharmacovigilance map of CEE and Balkan region | Dr. Mátyás Pétervári | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
| 16. | 20.09.2024 Friday | 15:30 | 45 | Latest scientific pharmacovigilance advancements | Dr. Szandra Marton | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
Vocational college(s)
| Numb. | Vocational college(s) |
|---|---|
| 1. | Internal medicine, endocrinology, diabetes and metabolic diseases |
| 2. | Angiology and vascular surgery |
| 3. | Clinical Pharmacology |
| 4. | Gastroenterological and hepatological |
| 5. | Home medicine |
| 6. | Neurosurgery |
| 7. | Cardiology |
| 8. | Traumatology and hand surgery |
| 9. | Medical laboratory |
| 10. | Oncology and radiation therapy |
| 11. | Surgery |
| 12. | Nephrology and dialysis |
| 13. | Neurological |
| 14. | Radiological |
| 15. | Orthopedic |
| 16. | Rehabilitation, physical medicine and medical aids |
| 17. | Rheumatology |
| 18. | Sports health |
| 19. | Heart surgery |